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Dear Innitius Community, As we closed out another transformative year, we’re excited to share some pivotal milestones that showcase how Innitius continues to grow and innovate. 2024 marked a significant shift from a single- product company to a multi- solution platform, positioning us to address broader challenges in women’s healthcare. Here are the highlights from 2024: General Update: This year, we transitioned from a single-product focus to a multi-solution platform, expanding our scope to include four strategic areas: TPTL (Threatened Preterm Labor), PTL (Preterm Labor Prognosis), IOL (Induction of Labor), and a Science Research Platform. This evolution reflects our commitment to addressing a broader range of challenges in women’s healthcare. Alongside this strategic shift, we finalized detailed plans and budgets for all our projects, setting a clear roadmap for success through 2028. Product Development Department: We achieved significant milestones in product development, the first eight CerviSense Intravaginal Probes, featuring a new design, were successfully manufactured, verified, and validated. These probes mark a critical step forward in our technology. Additionally, we completed development of the Research App, which enables seamless, automated data transfer from the probes to a database without manual intervention. This innovation is set to power our upcoming clinical trial at King’s College, starting in early 2025, focused on the PTL prognosis indication. Furthermore, the first version of the TPTL software app was delivered and underwent penetration testing, revealing minimal vulnerabilities that are scheduled to be addressed in 2025. Clinical Research: We successfully completed CT1, surpassing our targets for sensitivity (70%) and specificity (90%). These results significantly outperform traditional methods like cervical length measurement and biomarkers, validating our approach. We also finalized the first version of our algorithm, which exceeded expectations and delivered robust results. Building on this success, we designed the CT2 clinical trial protocol for the TPTL indication, in collaboration with the FDA through multiple Q-Submissions. This trial will launch in Spain and Germany in 2025. Clinical Trial 2 Sites: Spain: H. Universitario San Cecilio H. Universitario de Basurto H. Universitario de Cruces H. Universitario de Torrejón H. Clínic de Barcelona H. Sant Joan de Déu H. Vall d’Hebron H. Virgen Arrixaca H. Universitario La Paz H. Universitario de Málaga H. Universitario de A Coruña H. General Universitario Gregorio Marañón H. Universitario de Donostia H. Materno Infantil de Gran Canaria Germany: UKSH Lubeck University Hospital Johannes Gutenberg Mainz University Hospital Frankfurt Quality Assurance and Regulatory Affairs This year, we defined an accelerated market access strategy leveraging a Class I device for investigational use. This approach enables earlier market feedback and is expected to lead to commercialization by Q3 2025. Additionally, we worked closely with TÜV SÜD to align our ISO 13485 renewal and CE marking audits, ensuring compliance with the highest standards. Significant progress was also made in advancing regulatory pathways for our TPTL, PTL Prognosis, and IOL solutions. Research & Innovation Our efforts were bolstered by securing the Hazitek-Raginia grant, which supports the development of an automated cervix detection system. We also successfully completed the Hazitek SmartMed project, resulting in a prototype cloud platform that integrates diverse medical data. Moreover, we drafted our first scientific paper based on clinical trial results and algorithm performance, which is slated for publication in 2025. Team Achievements This year brought changes to our team, despite these changes, the team rose to the occasion and achieved all project objectives. We also strengthened our team with several strategic hires, including: Rut Salaverri as Head of Finance Clara Molinuevo as COO Hanan Elnazarova in Clinical Affairs Jon Ordeñana as Manufacturing Technician We are actively recruiting a Data Scientist to join us in 2025. Looking Ahead 2024 was a year of growth, transition, and achievement. We’re immensely proud of our team and grateful for the support of our community. With exciting milestones on the horizon in 2025, we’re committed to driving meaningful advancements in women’s healthcare.

Interview with Concepción Gómez Esteban, President of APREM (Asociación de Padres de Niños Prematuros) Dear Innitius Community, This month, we spoke with Concepción Gómez Esteban, President of APREM (Association of Parents of Premature Babies). Known as Concha, she has spent over 25 years advocating for premature babies and their families, a mission that began in 1999 when her twin sons were born extremely prematurely, weighing just 560 and 890 grams. This life-changing experience led her, along with other families, to found APREM, Spain’s first prematurity association. Concha, a tenured sociology professor at Complutense University of Madrid, has also made significant contributions to prematurity research. In this interview, Concha shares her insights on the challenges families face, the role of medical innovation, and the future of prematurity care. APREM has been supporting families of premature babies for over two decades. What inspired its creation, and how has its mission evolved over the years? “APREM was founded in 1999 by five families, all of whom had extremely vulnerable premature babies. We met at La Paz Hospital in Madrid and realized that facing such a situation alone was far more difficult than doing so as a group. At the time, prematurity was still largely unknown, and the only people who truly understood our struggles were those experiencing the same. We established an association to ensure that other families would not feel as alone as we did. That was the beginning of APREM—The first association of families with premature children in Spain. As pioneers, we gradually began helping families while also initiating a broader societal movement around prematurity in Spain. Today, after more than 25 years, APREM continues to be a leader in this space, paving the way for support and awareness. From the start, we knew the importance of formation. This differentiates APREM because we recognized that anything said to a parent in such a vulnerable situation—especially those with extremely premature babies—would stay with them forever. We understood that offering real support required proper training, not just sharing personal experiences.” How does APREM support families? “From the beginning, our focus has been on emotional support, which is essential in such critical moments. We provide guidance from trained professionals and currently handle around 700 inquiries a year. Over time, we have expanded our services, offering free psychological support, social work assistance, and virtual workshops. Our goal is to equip families with knowledge because caring for a premature baby requires a different approach.” What are the biggest challenges families of premature babies face, and how does APREM help address them? “The most immediate challenge is coping with the emotional turmoil of having a premature baby. Even if a parent is medically informed, seeing their fragile child in the NICU can be overwhelming. The situation is so intense that it can even lead to post-traumatic stress disorder. Because of this, psychological support is critical, even though many families struggle to ask for help. They also need formation to learn how to care for their child. APREM advocates for parental involvement as a crucial part of the healthcare team.” How do you see the role of innovative medical technologies, such as those developed by Innitius, in improving early detection and management of preterm labor? “I was truly excited when I first learned about Innitius’ work, and I immediately shared it with APREM. I met Rubén at an event where Innitius was receiving an award and was eager to connect with him. To my surprise, he wanted to connect with us as well. Right now, the most effective approach is prevention. While neonatal care has improved tremendously: the core issue remains: preventing preterm births. I really appreciate Innitius’ approach, which integrates maternal data, cervical assessment, and artificial intelligence. Your algorithm continues to improve, and I am particularly excited about the upcoming study in London, which has an impressive sample size. Innovations like this can help reduce false preterm labor diagnoses, unnecessary medication, and improve clinical decision-making.” APREM collaborates with healthcare professionals, institutions, and policymakers. What role does research and innovation play in shaping the future of preterm birth care? “Research is the key to improving and preventing preterm births. The most cutting-edge work, like what Innitius is doing, targets the root of the problem. Premature births carry significant emotional and financial costs for families and society. Reducing their occurrence benefits everyone. At APREM, we deeply value scientific research and actively contribute to it. Our credibility within the scientific community and among healthcare professionals stems from our commitment to evidence- based advocacy. Prevention is crucial, and technology plays a vital role in this.” How can technology providers like Innitius collaborate with patient advocacy groups like APREM to drive meaningful improvements in maternal and neonatal health? “Medical professionals, including those at Innitius, need to actively engage with families. Premature birth is extremely complex, and considering different perspectives is essential. Too often, patient associations are treated merely as tools—for signing letters of support or providing research samples—without recognizing the value of our insights. While this is improving, patient organizations are still sometimes viewed as outsiders rather than partners. Yet, collaboration is essential. By working together, we can provide better support for families. At APREM, we already work closely with professionals, ensuring that families receive the best possible care.” What are APREM’s key goals and initiatives for the coming years? “Our priority is continuity. In an increasingly individualistic society, supporting NGOs is becoming more challenging. Our aim is to keep APREM strong for another 25 years. We also want to expand our presence on the ground. Although we provide support nationwide, we are opening local branches—we currently have five and will soon establish a sixth. Having local peer support, such as mothers meeting other mothers, makes a tremendous difference. Additionally, we plan to enhance our educational programs for families. A particular concern of mine is the inclusion of vulnerable families in our initiatives. Social barriers, cultural differences, and even racism can make it difficult for some families to access critical resources

Dear Innitius Community, Preterm birth remains one of the biggest challenges in maternal healthcare, yet it is often misunderstood—even within the medical community. Despite advances in obstetrics, traditional methods for predicting preterm birth remain unreliable, leading to unnecessary interventions or missed opportunities for early treatment. The consequences of inaccurate diagnosis are significant: unnecessary hospitalizations, increased healthcare costs, and most importantly, missed chances to provide the right care at the right time. At Innitius, we are committed to challenging outdated assumptions and providing data-driven solutions that improve pregnancy outcomes. Let’s debunk some of the most common myths surrounding preterm birth prediction. Myth #1: Preterm Birth is Always Predictable with Current Methods Reality: Traditional diagnostic tools, including manual cervical exams, ultrasounds, and biochemical markers, are often inaccurate. Studies show that up to 50% of preterm labor diagnoses are incorrect, leading to either unnecessary hospitalizations or delayed interventions when they are truly needed. CerviSense, our patented torsional wave device, is changing this. By quantifying cervical softness, it offers an objective, real-time assessment that significantly improves accuracy over traditional methods. Myth #2: Ultrasound and Biomarkers are Enough for Accurate Prediction Reality: While ultrasound and biomarkers like fetal fibronectin (fFN) and phosphorylated insulin-like growth factor binding protein-1 (phIGFBP-1) are commonly used, their predictive power is limited: fFN sensitivity is only 20%, meaning most preterm labor cases go undetected. Current methods have a high false positive rate, leading to unnecessary medical interventions and increased healthcare costs. Cervical consistency has been identified as the most predictive factor, yet until now, there has been no way to measure it reliably. Myth #3: Preterm Birth Cannot Be Prevented Reality: While not all cases can be prevented, early detection is key to improving outcomes. More accurate diagnostics allow for: Timely administration of medications to improve fetal development. Better decision-making on hospital admissions, reducing unnecessary bed occupancy. The Future of Preterm Birth Prediction At Innitius, we are pioneering a new standard in obstetric diagnostics. CerviSense has been clinically validated in 10 hospitals—including Vall d’Hebron, La Fe, and Virgen del Rocío—and has demonstrated: 71% sensitivity vs. 20% in traditional biomarkers. 95% specificity vs. 89%, reducing false positives. Faster, real-time assessments, optimizing clinical workflows. By integrating AI-driven analysis and real-time data, CerviSense is eliminating guesswork and providing actionable insights for physicians. Let’s Change the Conversation Breaking these myths is critical to improving maternal and neonatal outcomes. It’s time to embrace scientific advancements that provide clarity, accuracy, and better decision-making in obstetrics. We invite you to explore how CerviSense is transforming preterm birth prediction. If you’re a healthcare professional, investor, or advocate for maternal health, let’s connect and discuss how we can shape the future of obstetric care together.

Dear Innitius Community, In our last newsletter, we reflected on 2024 and our transition from a single-product focus to a multi-solution platform. This strategic shift has allowed us to expand our impact across four key areas: Threatened Preterm Labor (TPTL), Preterm Labor Prognosis (PTL), Induction of Labor (IOL), and our Science Research Platform. This month, we take a closer look at each area and how Innitius is advancing solutions for women’s healthcare. Threatened Preterm Labor (TPTL) TPTL has been a core focus for Innitius since our inception. It remains the leading cause of hospitalization during pregnancy, with a significant economic burden—estimated at €8 billion in the EU and €1.2 billion in the US and EU combined. Preterm labor occurs before 37 weeks of pregnancy and is characterized by uterine contractions and changes in the cervix. When these clinical signs are absent, a diagnosis of TPTL is considered. However, only 15% of hospitalized TPTL cases result in spontaneous preterm birth within seven days, while 85% do not lead to preterm delivery. Accurately distinguishing true TPTL cases ensures necessary medical intervention while preventing unnecessary hospitalizations, reducing maternal stress, and minimizing healthcare costs. Preterm Labor Prognosis (PTL) Approximately 40% of preterm labor cases go undetected during mid-trimester ultrasound scans. This highlights the urgent need for improved diagnostic tools that can predict preterm labor more effectively, ensuring timely interventions for at-risk pregnancies. By integrating advanced diagnostic technologies like CerviSense, we aim to provide a more reliable approach for identifying preterm labor risks, enabling proactive clinical decisions that can improve maternal and neonatal health outcomes. Induction of Labor (IOL) Labor induction is a critical medical intervention used when the health of the mother or fetus is at risk, or when labor fails to progress naturally. However, it remains the number one cause of fetal distress during pregnancy. Shockingly, 20% of labor inductions fail, leading to prolonged fetal distress and unnecessary hospital stays of up to 48 hours. Failed inductions not only lead to extended hospital stays but also increase the likelihood of emergency interventions. The ability to accurately assess cervical readiness before initiating induction is crucial in preventing these complications. Science Research Platform Our Science Research Platform is a groundbreaking initiative aimed at creating the world’s largest cervix consistency database. By leveraging our CerviSense device, we provide researchers and clinicians with insights into cervical softness quantification. This data-driven approach paves the way for advancements in women’s healthcare, fostering innovation in diagnostics and treatment. The platform enables collaboration between leading obstetricians, researchers, and healthcare institutions, supporting research and the development of innovative approaches to pregnancy care. The Technology Behind It All: CerviSense At the heart of our multi-solution platform is CerviSense, a torsional wave probe that quantifies cervical softness. By combining real-time cervical softness data with AI-driven analytics, CerviSense allows healthcare providers to make more informed decisions, improving patient outcomes and reducing unnecessary medical interventions. Our vision is to continue refining this technology, ensuring that it becomes an indispensable tool in obstetric care worldwide. At Innitius, our mission remains clear: to develop breakthrough medical devices that enhance patient care through innovative technology. By addressing the most pressing challenges in obstetrics, we are shaping the future of maternal health. Stay tuned as we continue to drive change in women’s healthcare!